Largest online practice for women’s health now
offers the first FDA-approved long-lasting birth control method
that does not require a medical procedure
TherapeuticsMD, an innovative women’s healthcare company, and
Nurx, the largest online practice for women’s health, today
announced an arrangement to expand access to ANNOVERA® (segesterone
acetate and ethinyl estradiol vaginal system), a first of its kind
annual birth control ring. ANNOVERA is the first FDA-approved
long-lasting birth control method that does not require a medical
procedure. At a time when women are facing significant barriers to
reproductive healthcare, this arrangement will greatly expand
access to this highly effective and innovative form of
contraception to Nurx’s 300,000 patients across the country.
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the full release here:
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Nurx has seen a 50 percent increase in birth control requests
since early March, a trend that has continued as one in three women
are reporting significant difficulties accessing contraception and
reproductive healthcare due to the COVID-19 pandemic.1 Nurx has
also seen an increase in patients requesting longer-term forms of
contraception that can be administered at home, making ANNOVERA a
viable option for patients who are interested in a long-lasting,
self-managed, and effective form of birth control.
“We are excited to expand access to ANNOVERA via the Nurx
virtual clinic, which provides a convenient option for women to
consult with a doctor about reproductive treatment options as well
as the ability to receive their contraception with the convenience
of home delivery,” said TherapeuticsMD Chief Commercial Officer
Dawn Halkuff.
ANNOVERA is a flexible, silicone ring that is inserted into the
vagina and releases a steady dose of progestin and estrogen to
suppress ovulation and prevent pregnancy. ANNOVERA is self-inserted
and left in place for 21 continuous days and then removed for 7
days, a process that is repeated for each cycle. ANNOVERA should be
washed and dried before insertion and after removal and can be
stored in its plastic case during the 7 days removal. ANNOVERA is
effective for 13 cycles. Please see Important Safety Information,
including Boxed Warning, for ANNOVERA below.
“COVID-19 is magnifying existing barriers to women’s healthcare
while simultaneously introducing new roadblocks,” said Nurx VP of
Marketing Katelyn Watson. “As part of our commitment to empower our
patients and their reproductive health decisions, we’re excited to
partner with TherapeuticsMD and expand access to a novel,
convenient, and effective form of contraception.”
Nurx offers over 100 types of birth control, including the pill,
patch, ring, and shot, and accepts health insurance. Patients who
are interested in obtaining a birth control prescription through
Nurx are asked to complete a dynamic health survey through the Nurx
app. They are then matched with a Nurx medical provider who
consults with the patient. If the Nurx provider approves their
request, their birth control prescription will arrive in discreet
packaging. After their initial consultation, Nurx patients also
have unlimited access to their provider for one year, allowing them
to ask as many birth control questions as they'd like.
Nurx is available to nearly 90 percent of the U.S. population.
The full list of states where Nurx is available includes Alabama,
California, Colorado, District of Columbia, Florida, Georgia,
Illinois, Indiana, Iowa, Kentucky, Maine, Maryland, Massachusetts,
Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York,
North Carolina, Ohio, Oregon, Pennsylvania, South Carolina,
Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin.
Nurx patients can learn more about Annovera at
https://www.nurx.com/annovera.
IMPORTANT RISK INFORMATION
- Do not use ANNOVERA (segesterone acetate and ethinyl
estradiol vaginal system) if you smoke cigarettes and are over 35
years old. Smoking increases your risk of serious heart and blood
vessel (cardiovascular) side effects from hormonal birth control
methods, including death from heart attack, blood clots, or stroke.
This risk increases with age and the number of cigarettes you
smoke.
- ANNOVERA does not protect against HIV infection (AIDS) and
other sexually transmitted infections (STIs)
DO NOT USE ANNOVERA IF YOU
- have or have had a blood clot in your arms, legs, lungs, or
eyes.
- have had a stroke.
- have reduced blood flow to your brain (cerebrovascular
disease).
- have reduced blood flow or blockage in 1 or more of the
arteries that supply blood to your heart (coronary artery
disease).
- have had a heart attack.
- have heart rhythm or heart valve problems that increase your
risk of having blood clots, such as an infection of the inner
lining of the heart and heart valves or a type of irregular
heartbeat called atrial fibrillation.
- have a problem with your blood that makes it clot more than
normal.
- have high blood pressure that is not controlled with medicine
or have high blood pressure with blood vessel damage.
- have diabetes and are over 35 years old; have diabetes with
high blood pressure or problems with your kidneys, blood vessels,
eyes, or nerves; or have had diabetes for longer than 20
years.
- have headaches with changes in vision, numbness or weakness,
have migraine headaches with aura, or are over age 35 years old and
have any type of migraine headaches.
- have liver disease or liver tumors.
- have or have had breast cancer or any cancer that is sensitive
to the female hormones estrogen or progesterone.
- have unexplained vaginal bleeding.
- are allergic to segesterone acetate, ethinyl estradiol, or any
of the ingredients in ANNOVERA.
- take any Hepatitis C drug combination medicine containing
ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
WARNINGS
ANNOVERA can cause serious side effects, including: blood
clots; toxic shock syndrome (TSS); liver problems, including liver
tumors; high blood pressure; gallbladder problems; changes in the
sugar and fat (cholesterol and triglycerides) levels in your blood;
headache; irregular or unusual vaginal bleeding and spotting
between your menstrual periods; depression; possible cancer in your
cervix; swelling of your skin especially around your mouth, eyes,
and in your throat (angioedema); dark patches of skin on your
forehead, cheeks, upper lip, and chin (chloasma). Call your
healthcare provider or get emergency medical care right away if any
of these serious side effects occur.
The most common side effects of ANNOVERA include:
- headache, including migraine
- nausea/vomiting
- vaginal yeast infection (candidiasis)
- lower/upper abdomen pain
- painful periods
- vaginal discharge
- urinary tract infection
- breast pain/tenderness
- irregular vaginal bleeding
- diarrhea
- genital itching
USE
ANNOVERA is a ring-shaped vaginal system with hormones used by
females to prevent pregnancy.
ANNOVERA has not been adequately studied in females with a body
mass index >29 kg/m2.
The risk information provided here is not complete. To learn
more, review the ANNOVERA Patient Information and talk with your
healthcare provider or pharmacist. The FDA-approved product
labeling, including Patient Information, can be found at
ANNOVERA.com.
You may report side effects to the FDA at
www.fda.gov/medwatch or by calling 1-800-FDA-1088.
You may also report side effects to TherapeuticsMD at
1-888-228-0150.
Please note that this information is not comprehensive. For
Full Prescribing Information, including BOXED WARNING, please visit
annovera.com/pi.pdf.
About Nurx Nurx is a health tech company providing
convenient, affordable, and personalized care for sensitive health
needs. By reimagining the healthcare experience, Nurx offers
patients transparent pricing and judgement-free care whenever and
wherever works best for them. We believe everyone should have the
freedom to live well and be in charge of their healthcare
decisions, regardless of their circumstances. From diagnosis to
delivery, we make every part of getting healthy and staying
healthy, better.
About TherapeuticsMD TherapeuticsMD, Inc. is an
innovative, leading healthcare company, focused on developing and
commercializing novel products exclusively for women. Our products
are designed to address the unique changes and challenges women
experience through the various stages of their lives with a
therapeutic focus in family planning, reproductive health, and
menopause management. The Company is committed to advancing the
health of women and championing awareness of their healthcare
issues. To learn more about TherapeuticsMD, please visit
www.therapeuticsmd.com or follow us on Twitter: @TherapeuticsMD and
on Facebook: TherapeuticsMD.
Forward-Looking Statements This press release by
TherapeuticsMD, Inc. may contain forward-looking statements.
Forward-looking statements may include, but are not limited to,
statements relating to TherapeuticsMD’s objectives, plans and
strategies as well as statements, other than historical facts, that
address activities, events or developments that the Company
intends, expects, projects, believes or anticipates will or may
occur in the future. These statements are often characterized by
terminology such as "believes," "hopes," "may," "anticipates,"
"should," "intends," "plans," "will," "expects," "estimates,"
"projects," "positioned," "strategy" and similar expressions and
are based on assumptions and assessments made in light of
management’s experience and perception of historical trends,
current conditions, expected future developments and other factors
believed to be appropriate. Forward-looking statements in this
press release are made as of the date of this press release, and
the Company undertakes no duty to update or revise any such
statements, whether as a result of new information, future events
or otherwise. Forward-looking statements are not guarantees of
future performance and are subject to risks and uncertainties, many
of which are outside of the Company’s control. Important factors
that could cause actual results, developments and business
decisions to differ materially from forward-looking statements are
described in the sections titled "Risk Factors" in the Company’s
filings with the Securities and Exchange Commission, including its
most recent Annual Report on Form 10-K and Quarterly Reports on
Form 10-Q, as well as reports on Form 8-K, and include the
following: the Company’s ability to protect the intellectual
property related to its products; the effects of the COVID-19
pandemic; the Company’s ability to maintain or increase sales of
its products; the Company’s ability to develop and commercialize
IMVEXXY®, ANNOVERA®, BIJUVA® and its hormone therapy drug
candidates and obtain additional financing necessary therefor;
whether the Company will be able to comply with the covenants and
conditions under its term loan facility, including the conditions
to draw an additional tranche thereunder and whether the lender
will make such tranche available; the potential of adverse side
effects or other safety risks that could adversely affect the
commercialization of the Company’s current or future approved
products or preclude the approval of the Company’s future drug
candidates; whether the FDA will approve the efficacy supplement
for the lower dose of BIJUVA; the Company’s ability to protect its
intellectual property, including with respect to the Paragraph IV
notice letters the Company received regarding IMVEXXY and BIJUVA;
the length, cost and uncertain results of future clinical trials;
the Company’s reliance on third parties to conduct its
manufacturing, research and development and clinical trials; the
ability of the Company’s licensees to commercialize and distribute
the Company’s products; the ability of the Company’s marketing
contractors to market ANNOVERA; the availability of reimbursement
from government authorities and health insurance companies for the
Company’s products; the impact of product liability lawsuits; the
influence of extensive and costly government regulation; the
volatility of the trading price of the Company’s common stock and
the concentration of power in its stock ownership. PDF copies of
the Company’s historical press releases and financial tables can be
viewed and downloaded at its website:
www.therapeuticsmd.com/pressreleases.aspx.
Sources: 1 Early Impacts of the COVID-19 Pandemic: Findings from the
2020 Guttmacher Survey of Reproductive Health
Experiences
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version on businesswire.com: https://www.businesswire.com/news/home/20200715005282/en/
TherapeuticsMD Investor
Contact Nichol Ochsner Vice President, Investor
Relations 561-961-1900, ext. 2088 Nochsner@TherapeuticsMD.com
TherapeuticsMD Media Contact
Danielle Burrick Media Relations 212-445-8052
dburrick@webershandwick.com
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